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Washington Highlights: October 15, 2004

Congress Adjourns for Election; Leaves Spending Bills in Limbo

Congress has adjourned until after the election, putting off final decisions on domestic spending for FY 2005 until at least mid-November when the House and Senate return to Washington for a lame duck session. Prior to adjourning, Congress completed action on only four of the 13 regular appropriations bills. The chairmen of both the House and Senate Appropriations Committees have been predicting for months that the combination of tight spending limits and a congressional schedule compressed by primaries and the conventions would make it difficult to pass any spending bill other than those covering essential defense and homeland security efforts before the election. As a result, non-defense federal programs are currently operating under a continuing resolution (CR) that provides funding at FY 2004 levels through Nov. 20 [see Washington Highlights, Oct. 1].

The remaining appropriations bills are expected to top the congressional agenda for the lame-duck session scheduled for Nov. 16; however, legislators may struggle to complete action on the bills, as lame duck sessions are often non-productive in the absence of a compelling deadline. In addition, House and Senate leaders disagree vigorously about the various accounting maneuvers employed by the Senate Appropriations Committee to provide additional funds for the two major bills of interest to academic medicine: Labor-HHS-Education and VA-HUD-Independent Agencies.

Information:
Dave Moore, Senior Associate Vice President
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525

New GAO Report Analyzes Proposed Changes to Medicare Physician Payment Formula

The Government Accountability Office (GAO) Oct. 8 issued a report that concludes that any of the recently proposed changes to the Sustainable Growth Rate (SGR) system used to calculate Medicare physician payments "could be implemented in a way that would likely generate positive fee updates." The report, entitled "Medicare Physician Payments: Concerns About Spending Target System Prompt Interest in Considering Reforms" (GAO-05-85), was required under the Medicare Modernization Act (MMA) and delivered to the House and Senate Committees that oversee the Medicare program, also advises that any change to the SGR system "will be very expensive" and would increase Medicare spending on physician services from 4 to 23 percent during CY 2005 - CY 2012, depending on the type of change. Subsequently, the GAO warns that the implementation of any changes, "may hinge on whether primary importance should be given to stable fee increases of…fiscal discipline within the Medicare program."

Requested amid Congressional concerns that projected Medicare fee reductions for 2006 - 2012 will discourage physician participation and reduce beneficiary access to care, the GAO report analyzes the potential impact of specific changes to the SGR methodology. The report also details how the SGR methodology has helped "substantially" slow spending growth on physician services since its implementation in 1998.

Working in collaboration with the Centers for Medicare and Medicaid Services (CMS) Office of the Actuary (OACT), GAO estimates that eliminating the use of the SGR spending target and basing physician updates on annual increases in the cost of care (as proposed by the Medicare Payment Advisory Commission) would, from CY 2005 through CY 2014, "result in cumulative expenditures that are 22 percent greater than projected under current law." According to GAO, this would increase Medicare spending on Part B services from $16.9 trillion under current law to $19.1 trillion over the next 75 years.

In total, the GAO report analyzes six alternatives, including two scenarios that combine two or more options.

Information:
Christiane Mitchell, Senior Legislative Affairs Manager
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526

Clinical Trials Database Proposed

Legislation to establish a database for all clinical trials and their results was introduced Oct. 7 in both the House and Senate. The Fair Access to Clinical Trials (FACT) Act (S. 2933/H.R. 5252) would apply to clinical trials for drugs, biological products and medical devices, and would require researchers to report all results as well as information for patients seeking to enroll in studies.

Cosponsored by Senators Chris Dodd (D-Conn.), Edward Kennedy (D-Mass.), Tim Johnson (D-S.D.) and Ron Wyden (D-Ore.), and Representatives Edward Markey (D-Mass.) and Henry Waxman (D-Calif.), the FACT Act would create an electronic clinical trials registry to provide physicians, the general public, and patients seeking to enroll in clinical trials access to basic information about those trials. The FACT Act would require reporting of such details as research outcomes, basic demographic information on subjects, sources of funding for the trial, significant adverse events, and the product's FDA approval status.

The legislation would expand clinicaltrials.gov, a Web site established in 1997 and run by the National Library of Medicine at the National Institutes of Health, to include all clinical trials (except for preliminary safety trials) and also would require submission of all results, both positive and negative. In addition, the bill would continue clinicaltrials.gov as a resource for patients seeking to enroll in trials.

The proposal gives the Secretary of Health and Human Services oversight of the registry to determine whether required information has been submitted and whether submitted data are accurate. The bill mandates participation in the registry as a prerequisite for Institutional Review Board (IRB) approval. The bill also establishes strong enforcement mechanisms, including monetary penalties of up to $10,000 per day for manufacturers who refuse to comply.

Information:
Dave Moore, Senior Associate Vice President
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525